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,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,The U.S. Experience with,Total Artificial Hearts vs.,Left Ventricular Assist Devices,Lyle D. Joyce, M.D., PhD.,Division of Cardiovascular Surgery,The Mayo Clinic, Rochester, MN,USA,DEBAKEY ROLLER PUMP,1954,从实验角度来说，用人工装置代替心脏是可能的，这一点在动物身上已得到证实，实验动物可以存活长达,36,小时。而且我敢肯定，如果有足够的资金支持，尤其是在生物工程领域，那么人造心脏就能成为现实。,M. DeBakey,1963,美国国家心肺研究所开始实施 美国人造心脏方案 THE U.S. ARTIFICIAL HEART PROGRAM),1964,WILLEM J. KOLFF,首个左室辅助装置治疗下康复病例,1966,心脏支持辅助装置的开展历史,心脏移植前,类脉动式装置,完全人工或永久性支持设计,DeBakey VAD1966,Liotta TAH1969,Akutsu TAH 1981,Jarvik 7 TAH-1982,AKUTSU TAH,的临床植入,1981,Denton Cooley,1982,首例永久性,TAH,植入,里程碑式的转变: FDA通过了LVAD作为最终移植前的过渡治疗,1984,心脏大小差异带来的技术限制,TCI-THORATEC LVAD,Victor Poirier,1984, 1986,NOVACOR-WORLD HEART,Peer Portner,1984,持续流动装置的出现,Sarns,Biomedicus,Linearised Rate of Right Ventricular Failure,0.00,0.10,0.20,0.30,0.40,0.50,0.60,0-7,7-14,14-30,30,Days after LVAS Implant,Events/Recipient.month,REMATCH,试验,R,andomized,E,valuation of,M,echanical,A,ssistance for the,T,reatment of,C,ongestive,H,eart Failure,充血性心力衰竭机械辅助治疗的随机化评估研究,植入到装置失效时间,总体平均时间,332,天,(15-632),流入瓣衰竭,408,天,(240-632),动力装置失效,285,天,(15-439),Number of Days,通过轴流改进装置的小型化/微型化,1998,George Noon,HeartMate II,2800 Patients Implanted,53,先期研究,488,移植前过渡治疗,商业性植入,Europe: Post CE Mark,US: Post FDA Approval,648,最终治疗,HeartMate II,全球临床研究,1136,主要研究,As of March 2021,n=281,(18 mo follow-up),Durations,413 1 year,241 1.5 year,188 2 yr,42 3 yr,3 4 yr,1 5yr,DT 主要人群随访2年 May 2021,Cohorts:,Randomized vs XVE,XVE Exchange,Small pts,FDA Approval Apr 2021,HeartMate II,临床研究,有效支持时间,(n=281),中位数,: 155,天,(,最长：,5,年,),平均持续时间,: 237,天,181,患者年累积支持,87%,患者出院,78%,带着支持装置,10%,在心脏移植后,(prior to,index discharge),77%,的使用时间,(140,例年,),为院外使用时间,HeartMate II,实际存活曲线,Primary (n=133) and CAP (n=146) Cohorts,12 mo:,71,5%,6 mo:,77,4%,Remaining at risk,Primary: 133 48 32,CAP: 146 84 10,PRIMARY,CAP,As of Sep 14, 2007,6 mo:,87,3%,12 mo:,75,6%,Pagani et al AHA 2007,HeartMate II,临床试验,移植后存活率,移植后,30,天存活率,150/157 (96%),移植后一年存活率,117/128 (91%),HeartMate II,临床研究,致死因素,(56/281),HeartMate II,临床研究,不良事件,HeartMate II,临床研究,不良事件,Use of RVAD or extended inotrope use,14 days, or starting after 14 days,不良事件发生率比较HMII (n=281) vs HM VE BTT (n=280)1,1,Frazier, Rose, Oz et al JTCVS 2001,HeartMate II,无主要装置失效或置换事件率,(BTT, n=281),6 mo:,961%,12 mo:,932%,18 mo:,923%,Remaining at risk,281 131 72 52,Pagani et al (submitted 2021),VentrAssist,VentrAssist,HeartWare,DuraHeart,Matthews - Michigan,35% LVAD,患者出现右室衰竭,共,197,例患者,1996 2006,68,例,RV,衰竭患者中, 58,例为植入第一代,VAD,患者, 3,例为非脉动式,LVAD,患者。,RV,衰竭使,LVAD,患者的死亡几率增加了,6,倍,Dang - Columbia,39%,例出现,RV,衰竭,108 patients,1996 2004,CVP,的升高是唯一的独立预测因素,Potapov - Berlin,17% RV,衰竭,54 patients,1998-2006,Potapov Berlin,RV,衰竭的危险因素,三尖瓣关闭不全,右室的解剖形状,RV,的后负荷,脉动式和持续血流装置间无差异,Fitzpatrick - U Penn,37% RV,衰竭,266 patients,1995 - 2007,RVFRS Risk,(RV,衰竭危险评分,),需血管加压素,- 4,分,AST 80 -2,分,胆红素, 2.0 - 2.5,分,肌酐,2.3 - 3,分,AbioCor Implantable Components,Thoracic Unit,Implanted,Controller,Implanted,TET Coil,Implanted,Battery,14,例患者入选,4,个中心,12,例获得成功心脏支持,2,例出院,支持作用时间,: 53-512 days (17,个月,),累积支持：,5.2,例年,2,例围术期死亡,出血,79,岁,二次手术,泵工作,5,小时余,肺动脉血栓形成,弥漫的凝血病理改变,应用血液制品,CardioWest Total Artificial Heart,首例完全人工心脏移植,- Dr. Barney Clark,前景如何,?,完全人工心脏,左室辅助装置,左室辅助并短期右室辅助装置,(Hybrids),双室辅助装置,结论,完全人工心脏：从整体生理控制角度考虑，具有一定优势,心室辅助装置更容易接受,两个泵会,2,倍增加机械失效几率,无论结果怎样，期望辅助装置能更小,能效更高,可靠,植入易行,性价比更高,而且最好能完全植入,(,患者满意,).,英文原版,The U.S. Experience with,Total Artificial Hearts vs.,Left Ventricular Assist Devices,Lyle D. Joyce, M.D., PhD.,Division of Cardiovascular Surgery,The Mayo Clinic, Rochester, MN,USA,DEBAKEY ROLLER PUMP,1954,“Experimentally, it is possible to replace the heart with an artificial heart, and animals have been known to survive as long as 36 hours. This idea, I am sure, could reach full fruition if we had more funds to support more work, particularly in the bioengineering area. M. DeBakey,1963,NATIONAL HEART AND LUNG INSTITUTE ESTABLISHED THE U.S. ARTIFICIAL HEART PROGRAM,1964,WILLEM J. KOLFF,FIRST SUCCESSFUL LVAD BRIDGE TO RECOVERY,1966,History of Cardiac Support Devices,Pre-dates Cardiac Transplantation,Pulsatile Devices,Designed for Weaning or Permanent Support,DeBakey VAD1966,Liotta TAH1969,Akutsu TAH 1981,Jarvik 7 TAH-1982,CLINICAL IMPLANTATION OF AKUTSU TAH,1981,Denton Cooley,1982,FIRST PERMANENT TAH IMPLANT,Paradigm Shift: FDA Approval For Bridge to Transplantation Prior to Use as Destination Therapy,1984,TECHNICAL LIMITATIONS DUE TO SIZE,TCI-THORATEC LVAD,Victor Poirier,1984, 1986,NOVACOR-WORLD HEART,Peer Portner,1984,EMERGENCE OF CONTINUOUS FLOW DEVICES,Sarns,Biomedicus,Linearised Rate of Right Ventricular Failure,0.00,0.10,0.20,0.30,0.40,0.50,0.60,0-7,7-14,14-30,30,Days after LVAS Implant,Events/Recipient.month,REMATCH Trial,R,andomized,E,valuation of,M,echanical,A,ssistance for the,T,reatment of,C,ongestive,H,eart Failure,Implant to Failure Time,Overall Mean Time,332 days (15-632),Inflow valve failure,408 days (240-632),Motor Malfunction,285 days (15-439),Number of Days,MINIATURIZATION THROUGH AXIAL FLOW,1998,George Noon,HeartMate II,2800 Patients Implanted,53 Pilot Study,488 Bridge to Transplant,Commercial Implants,Europe: Post CE Mark and US: Post FDA Approval,648 Destination Therapy,HeartMate II Worldwide Clinical Experience,1136 Pivotal Study,As of March 2021,n=281,(18 mo follow-up),Durations,413 1 year,241 1.5 year,188 2 yr,42 3 yr,3 4 yr,1 5yr,DT primary cohort with,2 year follow-up May 2021,Cohorts:,Randomized vs XVE,XVE Exchange,Small pts,FDA Approval Apr 2021,HeartMate II Clinical Study,Support Duration (n=281),Median duration: 155 days (longest: 5.0 yr),Average duration: 237 days,181 pt-years cumulative support,87% patients discharged,78% on device support,10% following transplant (prior to index discharge),77% of time (140 pt-years) spent out of hospital,HeartMate II Actuarial Survival Primary (n=133) and CAP (n=146) Cohorts,12 mo:,71,5%,6 mo:,77,4%,Remaining at risk,Primary: 133 48 32,CAP: 146 84 10,PRIMARY,CAP,As of Sep 14, 2007,6 mo:,87,3%,12 mo:,75,6%,Pagani et al AHA 2007,HeartMate II Clinical Trial,Post-transplant Survival,30 Days Post-Transplant,150/157 (96%),One year post-transplant,117/128 (91%),HeartMate II Clinical Study,Causes of Death (56/281),HeartMate II Clinical Study,Adverse Events,HeartMate II Clinical Study,Adverse Events,Use of RVAD or extended inotrope use,14 days, or starting after 14 days,Adverse Event Rate Comparisons,HMII (n=281) vs HM VE BTT (n=280),1,1,Frazier, Rose, Oz et al JTCVS 2001,HeartMate II Freedom from Major Device Failure or Replacement (BTT, n=281),6 mo:,961%,12 mo:,932%,18 mo:,923%,Remaining at risk,281 131 72 52,Pagani et al (submitted 2021),VentrAssist,VentrAssist,HeartWare,DuraHeart,Matthews - Michigan,35% RV failure after LVAD,197 Patients,1996 2006,Of 68 cases of RV failure, 58 occurred in first generation VAD, 3 in non-pulsatile LVAD,Presence of RV failure adds 6 fold increase in odds of post-op LVAD death,Dang - Columbia,39% RV failure after LVAD,108 patients,1996 2004,Elevated CVP was only independent predictor,Potapov - Berlin,17% RV Failure,54 patients,1998-2006,Potapov Berlin RV Failure Risk Factors,Tricuspid incompetence,Geometry of RV,RV after-load,No difference between pulsatile and continuous flow devices,Fitzpatrick - U Penn,37% RV Failure,266 patients,1995 - 2007,RVFRS Risk (RV failure risk score),Vasopressor requirement - 4 points,AST 80 -2 points,Bilirubin 2.0 - 2.5 points,Creat 2.3 - 3 points,AbioCor Implantable Components,Thoracic Unit,Implanted,Controller,Implanted,TET Coil,Implanted,Battery,Fourteen Patients Enrolled at Four Centers,12 successfully supported,2 discharged,Supported duration: 53-512 days,(17 months),Cumulative support: 5.2 patient years,2 perioperative deaths,Bleeding79 yr.,reop, 5+ hr. pump run,Pulmonary artery thrombosisprofound,coagulopahy, given factor concentrates,CardioWest Total Artificial Heart,First Permanent Total Artificial Heart Implant- Dr. Barney Clark,What Will The Future Be?,Total Artificial Hearts,Left Ventricular Assists,Left Ventricular Assist with short term Right Ventricular Assist (Hybrids),Biventricular Assists,CONCLUSION,Total Artificial Hearts have the advantage when considering the value of full physiological control,Ventricular Assist Devices have more emotional appeal.,Two pumps could double the chance of mechanical failure.,Whatever the outcome, the,device(s,) will have to be small, energy efficient, reliable, easy to implant, cost-effective, and hopefully totally implantable (patient satisfaction).,
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